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Roche
donates a further 2 million treatment courses of antiviral Tamiflu
to the WHO for regional stockpiling |
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Basel,
17 January 2006
Roche announced today that it will donate another
2 million treatment courses, or 20 million doses,
of the antiviral Tamiflu (oseltamivir) to the World
Health Organization (WHO). This is addition to previous
donations made by Roche in 2004 and in August 2005,
and will result in a total of 5.125 million treatment
courses being available to the WHO to help people
affected by a potential pandemic.
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Tamiflu
for the treatment of influenza
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Whilst the
donation made last year is stored centrally, these additional
2 million treatment courses will be stored as regional stockpiles
in locations to be determined by WHO to serve the needs of developing
countries. The regional stockpiles of Tamiflu will be used to
reduce morbidity and mortality in the case of an outbreak of avian
influenza in humans and prevent the further spread of such an
outbreak, in the interest of public health.
“Roche is working as a collaborative and responsible partner with
governments and the WHO to assist in pandemic planning, including
the stockpiling of Tamiflu. We are pleased to be able to further
increase our donation to the WHO and help establish regional stockpiles
of Tamiflu”, commented William M. Burns, CEO Division Roche Pharma.
“By establishing regional stockpiles of antivirals, developing
countries most likely to be affected by avian influenza in humans
will be better prepared to rapidly manage outbreaks in the interest
of global public health. It is important to emphasize that this
and the previous donation(s) do not replace the need for countries
to consider the establishment of national antiviral stockpiles
as one of a number of measures of national pandemic preparedness
consistent with the national priorities of each country”, commented
Lee Jong-Wook, the Director-General of the World Health Organization.
In contrast to the regional stockpiles of Tamiflu, the “rapid
response stockpile” of 3 million courses of Tamiflu treatment
donated by Roche to the WHO in August 2005, will be used exclusively
at the site of outbreak of a pandemic in an attempt to contain
or slow its spread.
A comprehensive production network
In order to increase the availability of Tamiflu to meet the growing
demand as pandemic planning continues, Roche has taken significant
steps to increase manufacturing capacity, doubling production
capacity in 2004 and 2005 and will have the capacity to produce
over 300 million treatments of Tamiflu annually by 2007 - more
than a ten fold increase over the capacity in 2004. Roche has
established close relationships with 50 external suppliers and
the supply chain in place exceeds our current orders from Governments.
Roche is now in a position to have a back-up supply in case of
emergency and companies identified to take the capacity further
will allow Roche’s supply network to respond to future demands
from governments. Furthermore Roche has granted sublicenses to
manufacture oseltamivir to a Chinese and an Indian pharmaceutical
manufacturer.
About pandemics and H5N1
Influenza pandemics occur approximately every 40 years, and experts
caution that it is a case of when, not if, the next pandemic will
strike. The H5N1 avian influenza strain originating in Asia is
considered by experts to be the most likely source of the next
pandemic. Tamiflu is designed to be active against all clinically
relevant influenza viruses, including H5N1, and data suggest it
could be effective against any mutating strain of the virus– the
key to a pandemic. An orally administered treatment, Tamiflu is
systemically active, and can protect against the virus at all
sites in the body.
About Tamiflu (oseltamivir)
Tamiflu is designed to be active against all clinically relevant
influenza viruses and key international research groups have demonstrated,
using animal models of influenza that Tamiflu is effective against
the avian H5N1 strain circulating in the Far East.3
It works by blocking the action of the neuraminidase (NAI) enzyme
on the surface of the virus. When neuraminidase is inhibited,
the virus is not able to spread to and infect other cells in the
body.
Tamiflu delivers:
• 38 percent reduction in the severity of symptoms1
• 67 percent reduction in secondary complications such as bronchitis,
pneumonia and sinusitis in otherwise healthy individuals2
• 37 percent reduction in the duration of influenza illness5,3
• Tamiflu was shown to provide up to 89 percent overall protective
efficacy against clinical influenza in adults and adolescents
who had been in close contact with influenza-infected patients4
In children, Tamiflu delivers:
• 36 percent reduction in the severity and duration of influenza
symptoms5
• 44 percent reduced incidence of associated otitis media as compared
to standard care6
As with any antiviral, a theoretical potential exists for an influenza
virus to emerge with decreased sensitivity to a drug. Extensive
monitoring, by Roche and the independently established Neuraminidase
Inhibitor Susceptibility Network (NISN) measured the incidence
of resistance to NAIs. From around 4000 patients treated with
Tamiflu resistance was encountered in 0.4 per cent in adults and
4 per cent in children aged one to 12. This resistant virus was
found to be less virulent than the wild type virus and did not
affect the course of the illness.
The greatest use of Tamiflu today is in Japan. To illustrate this,
there were an estimated 16 million influenza infections in Japan
over the 2004/2005 influenza season. Roche estimates that around
6 million of those individuals infected with the influenza virus
received Tamiflu. Even with this degree of usage, resistance appears
very infrequent.
Avian Influenza and Pandemics
Most avian influenza viruses are not infectious to humans, but,
should an avian and a human influenza virus co-infect a human
or a pig, the virus strains can join, mutate and create a completely
new virus, which may be transmissible from animals to humans,
and from humans to humans. Such a strain would be entirely new
in composition, so vaccines developed and administered to date
to protect humans during seasonal epidemics, would be ineffective
against this new strain, leaving the population vulnerable to
infection. Experts believe the next influenza pandemic could result
from such a mutation of virus strains.
World Health Organisation
One of WHO's recommendations as part of its Pandemic Preparedness
Plan is that countries establish stockpiles of antiviral treatments,
which are effective against all strains of the influenza virus.
The Pandemic Preparedness Plan, along with details of the countries
that have implemented national plans, can be viewed on the Internet.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s
leading research-focused healthcare groups in the fields of pharmaceuticals
and diagnostics. As a supplier of innovative products and services
for the early detection, prevention, diagnosis and treatment of
disease, the Group contributes on a broad range of fronts to improving
people’s health and quality of life. Roche is a world leader in
diagnostics, the leading supplier of medicines for cancer and
transplantation and a market leader in virology. Roche employs
roughly 65,000 people in 150 countries and has R&D agreements
and strategic alliances with numerous partners, including majority
ownership interests in Genentech and Chugai. Additional information
about the Roche Group is available on the Internet (http://www.roche.com/).
All trademarks used or mentioned
in this release are legally protected.
Additional information
- Roche Health Kiosk, Influenza
- About
Tamiflu
- About
influenza
- WHO:
Global influenza programme
- WHO:
Avian flu
1 Treanor JJ et al. Efficacy
and safety of the oral neuraminidase inhibitor oseltamivir in
treating acute influenza: a randomized, controlled trial. JAMA
2000;283: 1016–24
2 Kaiser et al. Impact of Oseltamivir treatment on influenza-related
lower respiratory tract complications and hospitalisations. Arch
Intern Med. 163:1667-1672 (2003)
3 Nicholson KG et al. Efficacy and safety of oseltamivir
in treatment of acute influenza: a randomised controlled trial.
Lancet 2000; 355:1845–1850
4 Welliver R. W. et al. Effectiveness of oseltamivir in
preventing influenza in household contacts: a randomized controlled
trial. JAMA, 2001 Feb 14; 285(6): 748-754
5 Whitely RJ, Hayden FG et al; Oral oseltamivir treatment
of influenza in children, Pediatr Infect Dis J 2000; 20: 122-133
6 Roche data on file, 2003
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